Introduction
As per Clause 6 the management shall ensure provision of resources for proper functioning of all the processes and sub processes defined within an organization. Proper planning shall ensure timely provision of resources, thus counter losses due to delay.
Cost benefit ratio shall be assessed for outsourced
processes and sub process in comparison to in house competency and infrastructure.
The clause has four sub clauses which shall be justified in
quality manual sequentially. Procedures/methods/processes adopted by
organization for identification of resource need, provision of the identified
resource and continuous evaluation of resource needs shall be defined.
Resources
are required for implementation, maintenance, and continual improvement of QMS
as well as enhancement of customer satisfaction by meeting customer
requirements.
The resources are classified as:
Human
Resource
Infrastructure
Work
environment.
For a
pharma/biopharma segment the requirements of above resources are clearly
defined in GMP/ Regulatory guidelines. The organization in its quality manual
has to provide a map explaining how each requirement is addressed. References
of procedures/ processes employed for resource management shall be given.
| 6 | RESOURCE MANAGEMENT |
| 6.1 | PROVISION OF RESOURCES |
| 6.2 | HUMAN RESOURCES |
| 6.2.1 | General |
| 6.2.2 | Competence, Awareness & Training |
| 6.3 | INFRASTRUCTURE |
| 6.4 | WORK ENVIRONMENT |
6. RESOURCE MANAGEMENT
6.1 Provision of Resources
Top management has the responsibility
and authority for provision of resources.
Resources
are provided by the organization to ensure
implementation, maintenance and
continual improvement of the Quality Management System,
meeting customer and regulatory
requirements,
meeting requirements of manpower/personnel, infrastructure,
safety, security, working environment, process equipment, materials,
information, finance etc.
Resource
needs are determined during management review meetings, regular operations of
individual department, contract reviews, production plan, change control, new
specification requirements, corrective and preventive action, new product
readiness reviews, and training evaluations etc. Determination of these
requirements is also made through customer feedback, internal audits, and
monitoring / measuring activities among others.
Once the requirement of resource is determined (it may be in
the form of personnel assignments, allocation of space or equipment, training,
procurement decisions, budgets, etc), a documented request is initiated through
different resource provision channels such as warehouse, human resource,
purchase, projects etc.
6.2 Human resources
6.2.1 General
Management
ensures allocation of human resources among various functions, maximizing the
utilization of available personnel resources to achieve business goals and
performing the activities that are necessary in the maintenance of that
workforce through identification of staffing requirements, planning and
oversight of payroll and benefits, education and professional development, and administering
their work-life needs.
The efficient and effective deployment of personnel resources where and
when they are needed, and in possession of the tools, training and skills
required by the work is the main goal/focus of the departmental managers and
management (HR function).
6.2.2 Competence, Awareness and Training
Human
resource requirement for each process/sub process is defined through functional organogram. Selection criteria for
each position (including for personnel performing work affecting product
quality) is based on their education,
training, skill and experience in
the relevant field. This requirement is captured in a Job Description for each
position/function.
After
screening the employees are hired. All
employees undergo Induction Training Program following which they report to
their respective departments.
Departmental
managers are responsible for identifying competency requirements, assigning Job Responsibility and for providing training within departments
(departmental trainings). In-house
training is provided to the members to enhance their competency & skills to
perform the work more efficiently.
Departmental
managers are also responsible for training and awareness programs for
company-wide participation, such as: general orientation, rules and
regulations, quality system, safety, and other company-wide systems and issues.
Quality
Assurance and department managers ensure that employees understand the
importance and relevance of their work and how it contributes to the
achievement of Quality Objectives.
Appropriate
qualifications, along with required training, provide the competence required
for each position.
Based
on this process, competency is not compromised and the employees become the
most valuable resource for the organization.
Note: Training program shall be charted out for Temporary employee and contract
employees. These trainings shall include fundamental cGMP trainings, specific
trainings on duties assigned and safety training. Their training records shall
be maintain and archived by Quality department.
6.2.2.1 Training Needs Determination/ Identification of training needs and awareness programs
The
organization identifies personnel training needs, provides required training,
and evaluates the effectiveness of the training provided.
Quality
Assurance and Safety departments are responsible for identifying training needs
and awareness programs for company-wide participation, such as: general
orientation, rules and regulations, quality system, safety, and other
company-wide systems and issues.
Departmental managers are responsible
for identifying competency requirements and training needs in their districts,
and for requesting departmental training sessions. Departmental training is
primarily focused on increasing the level of skills in operating equipment and
processes, skills meeting changed/ updated job responsibilities, update with
current scientific knowledge, awareness of current regulatory and statutory
requirements, and other specific requirements determined by departmental head.
In addition, training needs or reviews are often identified in response to
corrective or preventive action requests, as nonconformities may have been
caused by inadequate training.
An
annual review is conducted with each employee, at which time the employee’s
training needs, as well as the effectiveness of the previous training are
discussed (Personal Development Plan).
Depending on results of
assessment of training needs, an Annual Training Calendar is drawn up in
consultation with departmental manager. Training is provided based on training
Calendar. Records of training are maintained as per Annual Training Calendar.
6.2.2.2 Training programs and training provisions:
The
trainings provided in the organization are categorized as follows:
Induction training Program: Introduces employee to the organization and explains its structure, operational
methodologies, processes unique to the organization, interaction of different
processes to ensure quality product/services and general orientation of organizations
QMS. Also gives introduction to requirements of product, customer and statutory
& regulatory requirements applicable to product/service and processes.
On Job / skill specific/ departmental training: Training of standard operating
procedure & specific skill, and personal qualification activities. The
training includes formal documented trainings as well as informal on job
trainings. It is primarily focused on increasing the level of skills in
operating equipment and processes, conducting inspections and testing, using
analytical and statistical techniques, and other such skills as appropriate for
particular positions and jobs.
After the training period (limited in
number of days such as 45 or 60) employees are evaluated against the position
requirements and if performance is found to be satisfactory, qualification for
the applicable position is awarded. Also when a procedure is created / updated
and implemented, those employees responsible for that specific process are
trained.
For personnel working under special
environmental conditions or for certain critical tasks (such as intermediate
and finished product testing, aseptic processing, work with hazardous and
dangerous substances etc.) a rigorous training under proper supervision is
provided and results evaluated. Only after satisfactory performance the
personnel is qualified for conducting the task/activity. Quality Assurance
shall ensure that all the training requirements are met and personnel are
qualified before any critical work is assigned to him/her.
Refresher trainings: It is a sub category of on job
training. It
reinforces quality awareness and knowledge of quality policy, objectives and
procedures, statutory and regulatory requirements and requirements of the
product.
Remedial training/ Retraining: It is
another sub category of on job training. These
trainings are conducted as a result of nonconformance, corrective and
preventive action, failure of Quality System etc.
Safety trainings: Instructs in safe working practices, use of personal protective
equipment, first aid, site specific and regulatory requirements. The training
is provided to all technical employees.
External training External seminars, conferences, and
courses: Provided
to individual employees on as-needed basis. This includes certification in
specialized skills.
Self study: Reading training manuals, magazines, books, and reports.
While all employees are encouraged to broaden their knowledge through reading,
in some cases self-studying may be required as formal training. The company supports continuing education programs by
reimbursing tuition for job related courses.
Trainings can be internal or external. Training may be executed by an expert
in the subject matter. The subject matter expert is obtained by: 1) hiring an
external consultant; 2) an internal employee who comes with the background in
education and experience applicable to the subject matter; or 3) an internal
employee only after completing an external course in the subject matter.
6.2.2.3 Effectiveness
Effectiveness
of training is evaluated using the following approaches:
immediate feedback
follow-up performance evaluation of
trained employees
testing and Certification of technical
personnel
review of the overall performance in
areas relevant to particular training programs;
consideration of competency and
training when investigating causes of quality system failures or process
nonconformities;
through the performance (of process
within QMS) review process.
Ultimately,
comprehensive measures such as productivity, on-time delivery, and customer
satisfaction are the most critical measures of training effectiveness.
Effective training will lead to the required competency
level of employees. It ensures that employees are aware of the relevance and
importance of their activities and how they contribute to the achievement of
the quality objectives.
6.2.2.4 Training records
Training records are established for all technical and
safety training. HR department maintains employee qualification and experience
records. All the records of the training sessions, copies of district request,
testing, and certification are maintained and archived by Quality Assurance
department. However, employee training summary shall be available at the
concerned department or the employee.
6.3 Infrastructure
Suitable facilities (physical
resources), work space, equipment, associated utilities, hardware,
software’s, supporting services (e.g,
communication, transport, logistics
etc), and other necessary infrastructure are determined, provided and
maintained, as required to achieve conformity to product requirements and meet
latest scientific and regulatory & statutory standards.
As
new infrastructure requirements arise, they will be documented in quality
plans.
6.3.1 Buildings, workspace and associated utilities
a. Infrastructure
and facilities, such as buildings, workspaces and associated utilities, etc.,
are appropriate and are properly maintained to achieve conformity to product
requirements and meet
latest scientific and regulatory& statutory standards.
Where product supplied may contaminate
other product/ personnel/environment, processes and / or procedures will be
created to ensure containment is effective.
Planning of new, and/or modification of
existing infrastructure and facilities is usually conducted in conjunction with
product or process changes; capacity and/or work force expansions; and other
such events. Facilities may also be expanded or modified to improve
productivity and/or quality, or to improve the work environment. The entire
process is performed within the framework of QMS and Regulatory requirements.
b. Departmental
managers are responsible for identifying the need and requirements for new,
and/or modification or repair of existing infrastructure and facilities in
their departments. Requests for changes and/or expansions of facilities are
submitted to the top management for review and approval through change control
procedure which is evaluated by regulatory department/expert before
implementation.
c. Maintenance of buildings and facilities
is performed internally as well as through external contractors (incase
in-house competency is not available). This includes regularly scheduled
maintenance of lighting systems, air conditioning and heating systems,
landscaping, and cleaning. Repairs of buildings and other such facilities are
contracted as needed. Engineering and Maintenance department is responsible for
coordinating and managing maintenance contracts.
6.3.2 Process equipment
Procurement of new, and/or modification of existing process
equipment (including hardware and software) are planned in conjunction with
development of manufacturing processes. The change is controlled through
established change control procedure and reviewed by regulatory
department/expert before implementation.
6.3.3 Supporting services
Supporting
services required by organization include logistics, transportation,
communication, pest control, solid waste disposal and information system
(etc.).
Logistics
and Transportation services are purchased from parcel delivery and courier
services, and from trucking or other transportation companies or consolidators,
as required. Transportation services are purchased. Logistics for the product
and raw materials are coordinated by warehouse/dispatch and approved by quality
assurance. Other transportation, shipping and parcel services are coordinated
by administration department.
Communication
services are provided by various telephone, wireless, and internet access
companies. Purchase department (or administration) is responsible for
administrating and coordinating these contracts.
IT
systems are implemented and maintained by internal (or outsourced) department.
The IT Manager (or engineering) is responsible for selecting
IT consultants and for administrating IT contracts.
6.3.4 Maintenance (Equipment and Facilities)
Maintenance
of the buildings and facilities is performed as per plan.
Key
process equipment, machines, hardware, and software are regularly maintained in
accordance with maintenance plans specified by equipment manufacturers or
departmental managers responsible for the equipment. Requirements for the
maintenance of production equipment are specified.
Where
process equipment/facility maintenance could affect product quality, the
required maintenance activities have been documented including frequency of
activity, or the lack of, and possible effects to product quality as required.
Equipment, machines, hardware and software are regularly
maintained in accordance with maintenance plans specified by equipment manufacturer.
6.4 Work Environment
The organization provides for its
employees suitable work environment needed to achieve conformity to product
requirements meet and/or exceed customer expectations.
Note: Factors that may affect
the conformity of the product include physical, environment and other factors
such as noise, temperature, humidity, lighting, weather, cleanliness, protection
from electrostatic discharge, etc.
Regarding physical factors, the company
employs a wide range of activities to monitor and improve workplace safety,
health, and ergonomics. These include adherence to good manufacturing
practices, safety team meetings, and training.
The requirements of work environment
(product related, human factor, health and safety) are determined during quality
planning and documented in the quality plan. The work environment is managed
for continuing suitability. Quality System review and its overall performance
provide data which is evaluated to determine if the work environment is
sufficient for achieving product conformance, or if preventive or corrective
action related to the work environment is required.
Requirements for
maintenance of the work environment are defined.
A. Product related requirements:
The company ensures environmental
conditions and other factors that may negatively impact product quality are
controlled and where appropriate monitored and measured. This may include basic
housekeeping and control at production, testing storage and distribution
stages.
Products
are protected on site by controls (temperature, humidity, moisture etc) within
the production and laboratories and by following environmental handling
requirements in Production and Testing procedures. Refrigerators and freezers are monitored manually
and/or by min-max thermometers or online recorders with alarms in
production. In areas where final
materials and finished products are stored (Finished Goods Manufacturing and
Distribution in Building), freezers and refrigerators are monitored by digital
display, chart recorders or online recorders with audio visual alarms. Retained
samples stored by Quality control are also monitored by digital display, chart
recorders or online recorders with audio visual alarms. Documented procedures are in place to define
these processes.
Storage
conditions for materials and products are mentioned in their documented
specifications, procedures and batch manufacturing records. Controls are in
place to ensure that materials and products are stored and shipped at the
correct temperatures and under the correct conditions, e.g. protected from
light, moisture, shock, vibration etc (as applicable).
B.
Human factors
Top Management and departmental Representatives are responsible
for ensuring suitable social and psychological conditions in the workplace.
This is to include such aspects as interaction and communication between
employees, employee harassment, conflict resolution and so forth. Relevant
workplace policies are implemented mainly through training and awareness
programs.
Where work environment is required to be monitored and controlled,
as to avoid having an adverse affect on product quality, the requirement(s)
will be included in the procedure for product manufacturing and control.
The work environment is air-conditioned and each person is
provided with a workspace and associated equipment/furniture to be able to
perform their tasks. The work environment is controlled for temperature,
lighting, cleanliness, and noise conditions. The company has documented
procedures for health, cleanliness and clothing of personnel, to prevent
adverse affect to the quality of the product. Additional requirements are
specified in production, testing, and cleaning & maintenance procedures.
Where applicable (e.g during production and testing) work environment controls required
in terms of health, cleanliness and sterilization are maintained. This includes
training and monitoring of these requirements.
Personnel whom may be required to temporally
work in special environmental conditions are properly trained or supervised by
trained personnel.
C.
Health and safety
Health and safety management system is independent from the
quality management system. It is administrated by the Safety Officer and is
documented in the Health and Safety (H&S) manual.
Procedures for production,
testing, cleaning, maintenance, assembly (etc.) defines the requirements for
personal protective equipment throughout the site. This policy is enforced by the Environmental
Health and Safety (EHS) Department and managed by the site departments.
EHS Management system
monitors and controls specific health and safety issues, provide instructions
for performing work in a safe and healthy manner. This includes trainings and
mock drills in different safety and health aspects.
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